Purpose
This notice describes changes in New Investigator policies stemming from the NIH Enhancing Peer Review Initiative (see http://enhancing-peer-review.nih.gov/index.html). Under this new policy, the NIH intends to support New Investigators at success rates comparable to those for established investigators submitting new applications. Early Stage Investigators (ESIs), as previously described on September 26, 2008 at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-121.html should comprise a majority of the New Investigators supported. Where possible, New Investigator applications will be clustered during review. This notice also advises New Investigators and ESIs that these NIH New Investigator Policies are limited to applications for traditional research project grant (R01) support. Accordingly, the NIH strongly encourages New Investigators, particularly ESIs, to apply for R01 grants when seeking first-time NIH funding.

Background
For more than three decades the NIH has explicitly encouraged New Investigators to apply for NIH research grant support. The involvement of New Investigators is considered essential to the vitality of health-related research and has been addressed by several important NIH programs and studies which are detailed on the NIH New Investigator Website at http://grants.nih.gov/grants/new_investigators/.

In FY 2007, the NIH adopted a policy designed to reverse the steady decline in the number of New Investigators that started in FY 20031. This policy was described in an NIH policy notice published on December 15, 20062. The policy adopted in FY 2007 also resulted in New Investigators having success rates comparable to established investigators who submitted new (Type 1) applications3. The NIH believes that sustaining comparable success rates between new and established investigators submitting Type 1 applications will serve as a useful way to ensure a steady and sufficient flow of New Investigators. This approach also will accommodate changing submission rates by both new and established investigators.

NIH recently announced the establishment of the Early Stage Investigator (ESI) category4. An ESI is a New Investigator who is within 10 years of completing his/her terminal research degree or is within 10 years of completing medical residency (or the equivalent). By encouraging ESIs to apply for NIH support, the NIH hopes to accelerate the transition to an independent scientific career with substantive NIH research grant support. Applications from ESIs will be identified so that the career stage of the applicant can be appropriately considered. Based on preliminary analyses, it is expected that ESIs will constitute the majority of New Investigators supported under this announced policy.

For the policy to be successful, NIH will continue to rely on a pool of high quality R01 applications from New Investigators including ESIs. There is concern, however, that applications from New Investigators frequently do not fare as well in peer review as those from established investigators. This concern is supported by reduced success rates on original and resubmitted Type 1 applications from New Investigators when compared to experienced investigators5. Currently, applications from New Investigators are interspersed with those from established investigators during the initial peer review process. This makes it difficult for reviewers to adequately consider the career stage of the applicant and to factor in differences in the availability of preliminary data and other elements. Accordingly, the NIH will, wherever possible, cluster applications from New Investigators for discussion during initial peer review with the expectation that those applications will be more effectively evaluated when judged against other applications from individuals at the same career stage.

Another issue which influences the number of New Investigators in the R01 pool is the use of other funding mechanisms. The NIH has found that the use of Small Grants (R03) and the NIH Exploratory/Developmental Research Grants (R21) has increased over the last few years6. However, recent analyses indicate that a smaller proportion of individuals with initial R21 or R03 grant support subsequently apply for and obtain R01-equivalent funding. In addition, the initial success rate for R21 applications often is lower than for R01 applications. Since R03 and R21 grants are limited in scope and period of support, they may not be the most effective way to launch an independent research career. Accordingly, the NIH encourages New Investigators, particularly ESIs, to apply for R01 grants when seeking first-time funding from the NIH.

Definitions

New Investigator:In general, a Program Director/Principal Investigator (PD/PI) is considered a New Investigator if he/she has not previously competed successfully as PD/PI for a significant NIH independent research award. For example, a PD/PI who has previously received a competing NIH R01 research grant is no longer considered a New Investigator. A complete definition of a New Investigator along with a list of NIH grants that do not disqualify a PD/PI from being considered a New Investigator can be found at http://grants1.nih.gov/grants/new_investigators/resources.htm.

Early Stage Investigator (ESI):An individual who is classified as a New or First-Time Investigator and is within 10 years of completing his/her terminal research degree or is within 10 years of completing medical residency (or the equivalent) is considered an Early Stage Investigator (ESI). More information on ESIs is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-121.html.

Policy

For FY 2009, NIH expects to support New Investigators at success rates equivalent to that of established investigators submitting new applications. Achievement of a comparable success rate should permit the NIH to support 1650 or more New Investigators across all Institutes and Centers, a number equivalent to that achieved in FY 2008.

The majority of New Investigators supported in FY 2009 are expected to be Early Stage Investigators (ESIs). As announced on September 26, 2008, the NIH will modify the data collection related to degree dates and medical residency within the investigator’s personal profile of the eRA Commons (https://commons.era.nih.gov/commons/). However, because most FY 2009 grant applications already have been submitted to the NIH, ESIs will be identified using available information in the application for FY 2009.

Applications from New Investigators will be clustered during initial peer review to the extent possible. Scientific Review Officers will consider the need to cluster applications from New Investigator depending on reviewer availability.